Method of performing anastomosis of blood vessels

ABSTRACT

A tubular anvil sleeve is defined by at least two sleeve portions pivoted to each other for movement about an axis radially outwardly offset from an axis of the tubular anvil sleeve in its closed position. A tubular graft is inserted into the tubular anvil sleeve and a projecting end portion of the graft is folded over an exterior of the tubular annular sleeve. The tubular annular sleeve and the overfolded portion of the graft is inserted into an excised end of a blood vessel after which staples are ejected in a conventional manner. The tubular annular sleeve is removed by axial motion followed by relatively pivoting the sleeve portions about the pivot axis of the sleeve portions to open the tubular annular sleeve and effect the withdrawal/removal thereof.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional application of Ser. No. 09/722,297filed on Nov. 28, 2000, and now U.S. Pat. No. 6,540,758.

FIELD OF THE INVENTION

The present invention pertains to the field of surgery and specificallyto surgical suturing devices for and methods of aortic dissectionincluding anastomosing a graft onto blood vessels, such as the aorta.However, the invention is equally applicable to joining any generallytubular vessels or organs to each other in end-to-end relationship.

One conventional way of connecting blood vessels is by the manualplacement of sutures which is time consuming and demands highlyspecialized skills. It usually takes about ten to twenty minutes tocomplete each anastomosis. For many operative interventions, a number ofsuch connections are required, and tissues which are deprived of bloodsupply during any particular procedure suffer from ischemia which canproduce degenerative and necrotic changes. Bleeding also occursfrequently from such manually performed anastomoses which prolongs andcomplicates the procedures. Other disadvantages of manual suturing areapparent and more frequently automatic staplers are now used forsuturing, particularly for suturing hollow organs in gastrointestinalsurgery. U.S. Pat. No. 5,720,755 (Dakov) discloses a stapler whichejects staples axially relative to the walls of flanged or cuffed bloodvessels, especially arteries, though such is said to be a difficult andtime consuming procedure, as compared to that of gastrointestinalorgans. One major difficulty involving cardiovascular surgery utilizingstaples for suturing is the limited space within the operative areawhich makes conventional methods unsuitable for use with blood vessels.The latter patent makes reference to U.S. Pat. No. 5,188,638 (Tzakis) asan example of suturing vessel walls which must be cuffed in order toperform the procedure. A major disadvantage of the stapling device ofthe latter patent is the utilization of an annular anvil which is of anelliptical or ellipsoid configuration formed by two split halves whichare lightly glued together. The annular anvil is not only difficult toposition incident to the performance of the anastomosis procedure, butat the completion thereof the anvil must be essentially “broken” intotwo separate pieces to effect the removal of the two anvil parts fromthe cuffed organ or vessel which is also necessarily tied down to theannular anvil in and against an annular outwardly opening groovethereof, normally by conventional manually applied sutures. Thus, afterthe completion of the stapling operation, the sutures must also beremoved and the annular anvil must thereafter be split and carefullyremoved which involves extremely delicate and facile efforts in arelatively small operative area.

BRIEF SUMMARY OF THE INVENTION

The present invention solves all of the aforementioned problems throughthe utilization of a novel suturing device, and particularly a noveltubular or annular anvil sleeve defined by at least two sleeve portionswhich are pivotally connected to each other for pivotal movement from afirst closed tubular stapling position to a second open removalposition. The pivoting motion is about a pivot axis which issubstantially parallel to but radially outwardly offset from an axisdefined by the tubular anvil sleeve in its closed position. Due to thelatter construction, the anvil sleeve can be axially slid from aninternal telescopic position relative to the stapled blood vessel and/orgraft while closed and thereafter can be pivoted to its open positionfor removal. The suture, glueing and “breaking” of the tubular anvil ofU.S. Pat. No. 5,188,638 is thus entirely eliminated along with thedisadvantages associated therewith.

With the above and other objects in view that will hereinafter appear,the nature of the invention will be more clearly understood by referenceto the following detailed description, the appended claims and theseveral views illustrated in the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a human heart, and illustrates variousportions thereof, including the aorta.

FIG. 2 is a highly enlarged perspective view of the aorta of FIG. 1 withportions broken away for clarity, and illustrates intimal andadventitial layers thereof, including an intimal tear in the intima orinner layer of the aorta.

FIG. 3 is a perspective view of a novel anvil for use with aconventional stapler, and illustrates a tubular anvil sleeve in itsclosed position formed of two semi-circular anvil sleeve portions withthe sleeve portions being pivotally connected to each other along apivot axis radially offset from an axis of the tubular anvil sleeve whenin its closed position, and a pivoted handle connected to one of theanvil sleeve portions.

FIG. 4 is a perspective view of the anvil or tubular anvil sleeve ofFIG. 3, and illustrates the tubular anvil sleeve in its open position,and a portion of the pivoted handle shown in phantom outlineillustrating two of many positions of use of the handle.

FIG. 5 is a perspective view of the anvil, and illustrates the tubularanvil sleeve in its closed position incident to telescopically receivingtherein a tubular Dacron® graft.

FIG. 6 is a perspective view of the Dacron® graft, and illustrates thesame incident to being telescopically inserted into the tubular anvilsleeve of FIG. 5.

FIG. 7 is a perspective view, and illustrates the tubular grafttelescopically inserted within the tubular anvil sleeve with an endportion of the tubular graft projecting to the right of the anvilsleeve, as viewed in FIG. 7.

FIG. 8 is a perspective view of the tubular anvil sleeve and the graftof FIG. 6, and illustrates the end portion of the tubular graft folded,overfolded or cuffed upon an exterior surface of the tubular anvilsleeve.

FIG. 9 is a perspective view, and illustrates the anvil with theoverfolded graft end portion inserted within an externally reinforcedend of the proximal end of the ascending aorta after the intimal tornportion of the aorta had been excised.

FIG. 10 is a perspective view similar to FIG. 9, and illustrates aconventional stapler in external surrounding relationship to the tubularanvil sleeve incident to ejecting staples radially inwardly to suturethe tubular graft to the externally reinforced proximal end of theascending aorta.

FIG. 11 is a perspective view similar to FIG. 10, and illustrates thetubular anvil sleeve and the stapler removed from the relationship shownin FIG. 10 with respect to the proximal end of the ascending aorta andrepositioned relative to the distal end of the ascending aorta incidentto stapling the reinforced end of the distal end of the ascending aortato an opposite overfolded portion of the graft.

FIG. 12 is a perspective view illustrating the removal of the tubularanvil sleeve, and illustrates the same after being drawn axiallydownwardly from the position shown in FIG. 11 to a position (not shown)surrounding only the tubular graft after which the tubular annularsleeve is pivoted, fully opened and radially withdrawn to theillustrated position.

FIG. 13 is a generally axially view taken along line 13—13 of FIG. 11,and illustrates the externally reinforced ends of the ascending aorta,the stapler, the tubular anvil and the overfolded end of the tubulargraft incident to closing the stapler and ejecting staples therefrom tocomplete the stapling.

FIG. 14 is a similar view taken along line 13–13 of FIG. 11, andillustrates the completion of the stapling operation.

FIG. 15 is a similar view take in along line 13–13 of FIG. 11, andillustrates the tubular anvil removed from the position of FIGS. 13 and14 and the completed anastomosis of the aorta.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A heart is illustrated in FIG. 1 of the drawings and is generallydesignated by the reference numeral H. The heart H includes a rightatrium RA, a left atrium LA, a right ventricle RV, a left ventricle LV,a pulmonary artery PA, and an aorta A. The aorta A includes an intimal(inner) layer or intima IL (FIG. 2) and an adventitial (outer) layer oradventitia AL. In Type A or Type 1 aortic dissection the intimal (inner)layer or intima IL is torn and defines a tear T in the ascending aortaAA. Blood B collects in the volume (unnumbered) between the layers AL,IL which during surgery necessitates dissection of an aortic portion APof the aorta A generally along lines of dissection LD1, LD2 therebyseparating a distal end or end portion Ea of the ascending aorta AA froma proximal end or end portion Ed of the ascending aorta AA. The two endsor end portions Ea, Ed of the ascending aorta AA, after the dissectedaorta portion AP and particularly the intimal portion thereof has beenexcised, are still quite fragile and the two layers AL, IL are stillseparated.

A surgical stapler 10 (FIG. 10) of the present invention is utilizedboth to reinforce each aortic end Ea, Ed with a bovine pericardium layerBPo on the outside which are held together with three or fourcircumferential rows R (FIG. 9) of staples S. The reinforcing bovinepericardium layer BPo makes it easier for anastomosing a graft G (FIGS.6 through 15) of Dacron® or equivalent material.

The surgical stapler 10 (FIGS. 10 and 11) includes a conventionalstapling device 11 corresponding to the anastomotic surgical fastenerdriving instrument of U.S. Pat. No. 5,188,638 and a novel anvil 20 ofthe present invention.

The stapling device 11 includes a pair of handles 13, 14 pivotallyconnected together by a pivot 15 and carrying respective annularstapling jaw halves 16, 17, each having one or more rows of cartridges18 which eject the conventional staples S radially inwardly in aconventional manner which will be described more fully hereinafter.

The anvil 20 (FIGS. 3 through 8 of the drawings) includes asubstantially tubular anvil sleeve 21 defined by at least two sleeveportions 22, 23, each of a generally semi-cylindrical configurationwhich are pivotally connected to each other by a pivot means 24 in theform of a conventional pivot. The sleeve portions 22, 23 includerespective inner surfaces 25, 26 and outer surfaces 27, 28, the lattertwo of which define a generally continuous exterior cylindrical surface27, 28 in the closed position (FIG. 3) of the tubular anvil sleeve 21.Conventional latching means 30 in the form of projecting male latchingtongues 30 are carried by the sleeve portion 22 and are releasablysnap-secured into female latch-receiving openings 31 of the sleeveportion 23. The male latching tongues 30 securely snap secure in thefemale openings 31 to retain the tubular anvil sleeve in its closedposition (FIG. 3) during the stapling operation, yet permit the snaprelease thereof in a conventional manner to effect pivoting of thesleeve portions 22, 23 relative to each other about the pivot 24 fromthe stapling position (FIG. 3) to the applying/removing position (FIG.4). The relative pivoting of the sleeve portions 23, 24 takes placeabout a pivot axis Pa (FIG. 4) which is radially outwardly offset froman axis Aa of the tubular anvil sleeve defined when in the closedposition thereof (FIG. 3).

The exterior surfaces 27, 28 include a plurality of shallow outwardlyopening cylindrical grooves 35 with four such grooves being illustratedand corresponding in location to the four cartridges 18 (FIG. 13) andthe staples S associated therewith.

A handle 40 is defined by a generally Y-shaped anvil portion 41 whichincludes a gripping portion 42 and a bight portion 43 having a first leg44, 45 pivoted together at 48 and a second leg 46, 47 pivoted togetherat 49 with the legs 45, 46 being welded or otherwise fastened to thesleeve portion 23. The pivots 48, 49 permit the manipulation of theanvil 20 when used in aortic dissection and anastomosis, as will bedescribed immediately hereinafter.

AORTIC ANASTOMOSIS

After the aortic portion AP (FIG. 2) has been dissected, the Dacron®graft (FIG. 6) is axially inserted into the closed tubular anvil sleeve21 in the manner graphically depicted in FIGS. 5 through 7 of thedrawings. Alternately, the Dacron® graft G can be seated upon or betweeneither of the sleeve portions 22, 23 when in the open position thereof(FIG. 4) after which the sleeve portions 22 and 23 are closed to theposition shown in FIG. 7. An end portion EP of the Dacron® graft Gprojects axially beyond (to the right, as viewed in FIG. 7) the anvilsleeve 21 and is thereafter reverse folded or folded over and generallyupon the exterior cylindrical surfaces 27, 28 of the closed tubularanvil sleeve 21 in the manner illustrated in FIG. 8 with the foldedportion of the Dacron® graft G being designated by the referencecharacter FP. The folded portion FP is then inserted into either thedistal end Ea of the ascending aorta AA or the proximal end Ed of theAscending aorta AA, and in FIG. 9 the folded portion FP is showninserted into the proximal end Ed of the ascending aorta AA sufficientlyfor receipt therein of the tubular anvil sleeve 21. Thus, the foldedportion FP of the graft G and the anvil sleeve 21 are inserted insidethe intima IL which is enveloped or telescoped over the same and alsowithin the adventitial AL after which an outer reinforcing layer ofbovine pericardium PBO is positioned in surrounding relationship to theexterior of the adventitial AP and in surrounding relationship to theunderlying folded portion FP of the Dacron® graft G. Thereafter, thestapling device 11 is manipulated from an open position to the closedposition shown in FIG. 10 in which the stapler jaw halves 16, 17telescopically exteriorly embrace the reinforcing bovine pericardiumouter layer PBo, the underlying portions of the adventitia AP and intimaAL and the overfolded portion FP of the Dacron® graft G after which thestaples S are fired resulting in the anastomosis shown at the left sideof FIG. 13 after the anvil has been removed by simply sliding the anvilsleeve 21 to the left, as viewed in FIGS. 9 and 10 beyond the Dacron®graft G. At this stage of the anastomosis, the tubular anvil sleeve 21need not be opened to remove the same after the performance of thestapling operation because the left hand end of the graft G, again asviewed in FIGS. 9 and 10, is free and the closed anvil sleeve 21 can beslid to the left and freely removed therefrom.

The distal end Ea of the ascending aorta AA is next anatomized bypositioning an end portion EP′ of the Dacron graft G opposite the endportion EP thereof in overfolded or folded relationship to the closedtubular anvil sleeve 21 in the manner illustrated in FIG. 13 of thedrawings. The end portion EP′ can be telescoped into the closed tubularanvil sleeve 21 or positioned within the opened sleeve portions 22, 23thereof (FIG. 4) after which the latter are closed and the end portionEP′ is then folded to the position shown in FIG. 13, just as was earlierdescribed with respect to the end portion EP. The handle H isappropriately manipulated during this procedure, including during theinsertion of the tubular anvil sleeve 21 and the end portion EP′ of thegraft G into the distal end Ea of the ascending aorta AA, in the mannerillustrated in the right hand side of FIG. 13. Once again, an outerreinforcing layer of bovine pericardium BP'o is positioned insurrounding relationship to the exterior of the adventitia AL (FIG. 13),the stapler jaw halves 16, 17 are positioned as shown in FIG. 13,eventually closed (FIG. 14) and the staples S are ejected from thecartridges 18 in a conventional manner resulting in the completion ofthe anastomosis of the aorta A, except, of course, for the removal ofthe closed tubular anvil sleeve 21 from the position shown in FIG. 14.

Referring specifically to FIG. 14, the anvil 20 and specifically thetubular anvil sleeve 21 is removed from the anatomized aorta A and theexternal surrounding relationship of the sleeve 21 to the Dacron® graftG by first sliding the closed tubular annular sleeve 21 to the left fromthe position shown in FIG. 14 to the position shown in FIG. 15 byappropriately manipulating and pulling the handle 40 until the closedanvil sleeve 21 is positioned generally as illustrated in FIG. 15.Thereafter, the latching means 30, 31 are unlatched, the sleeve portions22, 23 are opened, and the anvil 20 can be readily removed from theanatomized aorta A.

Although a preferred embodiment of the invention has been specificallyillustrated and described herein, it is to be understood that minorvariations may be made in the apparatus without departing from thespirit and scope of the invention, as defined the appended claims.

1. A method of repairing a damaged blood vessel comprising the steps ofremoving a damaged portion of a blood vessel, providing a tubular graft,positioning the tubular graft at least partially within a tubular anvilsleeve having an exterior surface, folding an end portion of the tubulargraft projecting beyond the tubular anvil sleeve into overylyingrelationship to the tubular anvil sleeve exterior surface, inserting thefolded end portion and tubular anvil sleeve into a remaining end of theblood vessel from which the damaged vessel portion was removed, drivingstaples through the blood vessel remaining end and the folded over endportion to effect staple closure against the tubular anvil sleeveexterior surface, axially sliding the tubular anvil sleeve to effect thewithdrawal thereof from the stapled folded end portion, and after theaxial sliding withdrawal of the tubular annular sleeve from the stapledfolded end portion separating the tubular anvil sleeve along a chordalplane to effect the removal of the tubular anvil sleeve from the tubulargraft.
 2. The method as defined in claim 1 wherein the separating stepis performed by pivoting the tubular anvil sleeve to an open position bypivotal movement about an axis substantially parallel to and radiallyoutwardly offset from an axis of the tubular anvil sleeve.
 3. The methodas defined in claim 2 including the steps of repositioning the tubulargraft at least partially within the tubular anvil sleeve after theperformance of the separating step, folding a second end portionopposite the first-mentioned end portion of the tubular graft projectingbeyond the tubular anvil sleeve into overlying relationship to thetubular anvil sleeve exterior surface, inserting the folded second endportion and tubular anvil sleeve into a second remaining end of theblood vessel from which the damaged vessel portion was removed, drivingstaples through the blood vessel second remaining end and the foldedover second end portion to effect staple closure against the tubularanvil sleeve exterior surface, axially sliding the tubular anvil sleeveto effect the withdrawal thereof from the stapled folded second endportion, and separating the tubular anvil sleeve along a chordal planeto effect the removal for of the tubular anvil sleeve from the tubulargraft.
 4. The method as defined in claim 1 including the steps ofrepositioning the tubular graft at least partially within the tubularanvil sleeve after the performance of the separating step, folding asecond end portion opposite the first-mentioned end portion of thetubular graft projecting beyond the tubular anvil sleeve into overlyingrelationship to the tubular anvil sleeve exterior surface, inserting thefolded second end portion and tubular anvil sleeve into a secondremaining end of the blood vessel from which the damaged vessel portionwas removed, driving staples through the blood vessel second remainingend and the folded over second end portion to effect staple closureagainst the tubular anvil sleeve exterior surface, axially sliding thetubular anvil sleeve to effect the withdrawal thereof from the stapledfolded second end portion, and separating the tubular anvil sleeve alonga chordal plane to effect the removal of the tubular anvil sleeve fromthe tubular graft.
 5. The method as defined in claim 4 wherein thelast-mentioned separating step is performed by pivoting the tubularanvil sleeve to an open position by pivotal movement about an axissubstantially parallel to and radially outwardly offset from the axis ofthe tubular annular sleeve.